Cassidy, who is chairman of the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP), reminded Makary about the commitments he and Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. made during their confirmation hearings to review the safety data around mifepristone, the first drug used in a two-drug medication abortion regimen.
“Despite making these commitments to senators in the beginning of the year, FDA waited nearly six months after your confirmation before announcing any concrete action to evaluate and mitigate the safety risks of mifepristone, and even then, did so in a non-public letter to state attorneys general without any press release or public acknowledgement of the letter until a post on X by Secretary Kennedy on October 2, 2025,” senators wrote, noting that the agency has provided little information about the details of its review of the drug.
Republican lawmakers have specifically asked health agencies to look at the potential impacts of the previous Biden and Obama administration actions removing safeguards for mifepristone. In their letter, senators pointed to a 2016 action removing the Risk Evaluation and Mitigation Strategy (REMS) requirement for prescribers to report non-fatal adverse events to abortion pill drug manufacturers, followed by the Biden administration’s 2021 move halting the in-person dispensing requirement for mifepristone, and the solidification of its mail-order abortion policy in 2023.
The senators noted:
All of this happened without any evidence to justify the departure from 20 years of precedent requiring this dangerous drug to be dispensed in-person where a proper medical examination could be conducted to ensure a woman does not have an undiagnosed ectopic pregnancy, does not take the chemical abortion drugs too late in pregnancy, and does not have Rh-factor incompatibility that could put future pregnancies at risk, among others. …
The in-person dispensing requirement also helped guard women from being coerced into having chemical abortions against their will. Since its removal in 2021, multiple news reports indicate that women have been forced to take chemical abortion pills or even given them without their knowledge,” the lawmakers continued. “In one case in Texas, a man was convicted of repeatedly attempting to kill his unborn child by secretly spiking his pregnant wife’s drinks seven times with chemical abortion drugs. In another case in Louisiana, a woman was charged with obtaining chemical abortion drugs through the mail and forcing her teenage daughter to take them to end her unborn child’s life. Tragically, these are just some of the many stories of the danger caused by removing the in-person dispensing requirement.
Even so, the FDA earlier this month approved a generic form of the abortion pill produced by Evita Solutions LLC, a company that says its mission is to “normalize abortion” and make it “accessible to all.” In the FDA’s letter to Evita Solutions LLC, the agency said it concluded the drug is “bioequivalent and therapeutically equivalent” to the brand name mifepristone drug Mifeprex, which is made by Danco Laboratories, and has therefore met the requirements for approval.
Breitbart News reached out to the FDA for comment at the time about the drug’s approval and asked whether the agency is still conducting a safety review of mifepristone. HHS communications director Andrew Nixon told Breitbart News the FDA has “very limited discretion in deciding whether to approve a generic drug.”
“By law, the Secretary of Health and Human Services must approve an application if it demonstrates that the generic drug is identical to the brand-name drug,” Nixon said. “Generic applicants are not required to submit independent evidence proving safety and effectiveness.”
Nixon said HHS is still conducting a study on the reported adverse effects of mifepristone “to ensure the FDA’s risk mitigation program for the drug is sufficient to protect women from unstated risks.”
“The FDA does not endorse any drug product and directs prescribers to follow all labeling,” he added.
In a statement to X following conservative and pro-life backlash, Secretary Kennedy emphasized his commitment to “review all the evidence — including real-world outcomes — on the safety of this drug. Recent studies already point to serious risks when mifepristone is used without proper medical oversight.”
“FDA only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug,” he added.
Senators are now demanding more clarity around the agency’s review “[i]n light of the FDA’s approval of another means of chemical abortion under the same flawed REMS framework…”
“To be clear: this approval fails to mitigate the risks to women that have been identified and fails to protect women from the coercive use of the drug,” they wrote. “It also flies in the face of President Trump’s strong statement that he is ‘the most pro-life president’ in history and his dedication to protecting the lives of unborn children and keeping women safe,” they wrote.
Senators asked Makary to respond to several questions by Oct. 30, 2025, including clarifications about Kennedy’s September comments saying the Biden administration “twisted” mifepristone safety data. They also asked about the REMS process, data on serious adverse events, progress in studies assessing the safety of mifepristone, including timeframe and scope, whether there are any ongoing studies about the impacts of removing the in-person dispensing requirement, and questions about the timeline of the approval of the new generic abortion pill.
“Thank you for your prompt attention to this important matter,” they wrote.
The letter comes a week after 51 Republican senators sent a letter to Kennedy and Makary urging them to reevaluate the FDA’s decision to approve a new generic version of the abortion pill.
In 2023, medication abortions accounted for 63 percent of all abortions within the formal U.S. healthcare system — meaning an estimated 642,700 unborn babies died in medication abortions, according to the pro-abortion Guttmacher Institute. The percentage was up from an estimated 53 percent in 2020 and 39 percent in 2017. The report did not account for abortion pills obtained through underground national and international networks, including those that send pills to women in states with abortion restrictions.
In a medication abortion, mifepristone blocks the action of progesterone, which the mother’s body produces to nourish the pregnancy. When progesterone is blocked, the lining of the mother’s uterus deteriorates, and blood and nourishment are cut off to the developing baby, who then dies inside the mother’s womb. The drug misoprostol (also called Cytotec) then causes contractions and bleeding to expel the baby from the mother’s uterus.
Cassidy’s letter was joined by Sens. Tommy Tuberville (R-AL), Rand Paul (R-KY), Josh Hawley (R-MO), Pete Ricketts (R-NE), Mike Lee (R-UT), James Risch (R-ID), John Cornyn (R-TX), James Lankford (R-OK), Lindsey Graham (R-SC), Ted Budd (R-NC), Marsha Blackburn (R-TN), Roger Wicker (R-MS), Jon Husted (R-OH), Steve Daines (R-MT), Tim Scott (R-SC), and Michael Rounds (R-SD).
Katherine Hamilton is a political reporter for Breitbart News. You can follow her on X @thekat_hamilton.
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